Infusion pumps are used to administer various types of drugs, nutritional compositions, and prescribed fluids or fluid-like substances (collectively, “medicaments”) to patients in volume- and/or time-controlled doses. The pumps can be used to transfer medicaments, that are stored in storage containers such as cassettes and bags, to be administered to patients via infusion systems through various routes of delivery, such as intravenously, neuraxially, and enterally. Of necessity, the infusion systems typically include various conduits and connectors for connecting the storage containers to the pumps, and the pumps to patients.
Luer connectors are commonly used to make leak-free connections between medicament containers, conduits, pumps and patients. A Luer male-taper fitting can quickly and effectively be inserted into a corresponding female part to effect a reliable fluid tight connection. Notwithstanding the effectiveness and ease of use provided by Luer connectors, concern has grown regarding the widespread use of a single type of connector in multiple applications that can be inherently incompatible. In particular, the use of a single type of connector invites the possibility of misconnecting a fluid source to an incompatible route of delivery. A medicament to be delivered enterally through a percutaneous endoscopic gastrostomy PEG tube, for example, could mistakenly be administered intravenously by misconnection to a peripheral cannula, if both the PEG tube and the cannula were fitted with the same type of connector. Even the same type of medicament will have different dosages depending on the route of delivery; and misapplication of either the medicament or the dosage through an inappropriate route of delivery can negate the curative benefit of the drug, and can, in some circumstances, even be fatal.
In an effort to reduce the potential for a misconnection leading to the introduction of a particular medicament via an undesired route of delivery or other error in dosage or administration, some health care facilities will mandate the use of certain pumps for certain routes of delivery or other such dedicated protocols in their health care facilities. For example, a particular brand and model of pump could be exclusively designated for use in neuraxial delivery applications. Users within a particular facility could be trained to recognize the particular brand and model of pump as being exclusively dedicated to the designated route, thereby reducing the chance of a wrong route administration for a particular patient. Such ad hoc efforts, however, do not provide the benefits of a universal standard; instead, these ad hoc efforts tend to artificially restrict the use of the health care facility's inventory of pumps while not necessarily restricting access as desired to improper delivery routes and the like.
ISO 80369, Small-bore Connectors for Liquids and Gases in Healthcare Applications (incorporated herein by reference in its entirety), is an emerging International Standard for connectivity between medical devices, patients, and accessories. Part 1 of ISO 80369, General Requirements (incorporated herein by reference in its entirety), was published in 2010, and Parts 2-7, addressing particular applications, are works in progress at the time of this disclosure. The ISO 80369 standard assigns specific connectors to specific routes of delivery, and makes those specific connectors exclusive to their designated route. Segregating medicaments by route of delivery, and designating unique connectors for the different routes of delivery, is intended to reduce the opportunity for administration of a particular medicine via an inappropriate route of delivery.
The primary routes of delivery for medicament infusion systems are intravenous (IV), neuraxial, and enteral. Examples of infusion pumps used in medicament infusion systems include so called ambulatory pumps such as those sold by the assignee of the instant invention under the trade names CADD™ Prizm, Cadd™ Legacy, and CADD™ Solis. Such pumps are multipurpose pumps in that each can be used with an IV, neuraxial or enteral route of delivery, as well as others, by simply programming the individual pump appropriately. It will be understood that although this disclosure refers to and presents examples of particular pumps, embodiments applicable to any pump intended for administering medicaments such as syringe pumps, large volume pumps, elastomeric pumps and the like, while still other embodiments are applicable to devices and situations other than those involving or relating to medical pumps (e.g., using gravity-fed bags, in non-medical uses, etc.). On the other hand, ISO 80369, as a connectivity standard, segregates the connectors to be used for those three routes into separate categories, the connectors for each category being incompatible with, and unconnectable to, connectors from the other categories. While a multipurpose infusion pump can be used in different applications and for different delivery routes, the function of the pump needs to match, and needs to be restricted to, the delivery route it is assigned to, as do the connectors that incorporate the multipurpose pump into the infusion system, if the benefits of a connectivity standard are to be realized.
Conversion from Luer connectors to fully ISO 80369-compliant connectors will be a gradual process. For example, clinics will likely have a mix of Luer and neuraxial ISO 80369-6 devices that need to interconnect. Adapters are required that allow Luer connectors to attach to other ISO 80369 compliant devices. In the spirit of the ISO 80369 standard, it is desirable to provide a permanent, tamper-proof conversion from Luer connectors to other compliant devices.